European Medicines Agency approves 100th herbal Community monograph

News

27/04/2012

European Medicines Agency approves 100th herbal Community monograph

The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved its 100th herbal Community monograph since the Committee began work in 2004. This is a significant achievement for the Committee and a key step in in supporting the harmonisation of procedures and provisions for herbal medicinal products within the European regulatory framework.

The information contained in a herbal Community monograph is used by Member States to support the evaluation of marketing applications from companies for medicines containing a herbal substance, a herbal preparation or a combination of one or more of both herbal substances and herbal preparations.

A Community herbal monograph comprises the HMPC’s scientific opinion on the herbal medicine based on its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use) and includes:

what the herbal product is used for;

who can take the herbal product (e.g. adults only or children as well, in pregnant and lactating women, etc.);

safety information such as information regarding undesirable effects and interaction with other medicines.

All of the Committee's assessment work on herbal medicinal products including the herbal Community monographs can be searched under herbal medicines for human use.